Neurological Changes With a Memory Self-efficacy Training Protocol

NCT ID: NCT04077320

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-09-23

Brief Summary

Confidence in one's ability to accomplish a task, more formally known as self-efficacy, is an important psychological variable that can influence how the investigators perform on various tasks. Previous studies have shown that self-efficacy is a modifiable trait that can be improved and bolstered with training and practice. More importantly for this study, memory self-efficacy has been shown to be modifiable for older adults, consequently improving their performance on memory tasks. While there is evidence to support the importance of memory self-efficacy for successful memory performance in older adults, the underlying neurological changes that accompany these performance changes have not been explored. The goal of this study is to examine the changes in brain activity before and after a memory self-efficacy training program to better understand the mechanisms of both memory and self-efficacy.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Memory Self-Efficacy Training

Memory self-efficacy group training classes.

Group Type: EXPERIMENTAL

Memory Self-Efficacy Training

Intervention Type: BEHAVIORAL

The intervention will consist of a six-week cognitive behavioral intervention integrating the four pillars of self-efficacy, Mastery, Social Modeling, Coaching, and Physiological Responses (West et al. 2008). Each week will comprise of a 1.5 hour session which focuses on an educational component, discussions and active learning practice activities to apply lesson material. Additionally, participants will be given take home exercises to practice outside a classroom setting. The sessions will be conducted in small groups of 4-6 people.

General Education Group

General education group classes (e.g., exercise, diet, sustainability, tc.)

Group Type: ACTIVE_COMPARATOR

General Education

Intervention Type: BEHAVIORAL

The active control intervention will be a general education class consisting of real world knowledge and factual information on various topics unrelated to memory. This intervention will follow the same format as the memory self-efficacy training arm. One 1.5 hours session every week for 6 weeks, in small groups.

Interventions

Memory Self-Efficacy Training

The intervention will consist of a six-week cognitive behavioral intervention integrating the four pillars of self-efficacy, Mastery, Social Modeling, Coaching, and Physiological Responses (West et al. 2008). Each week will comprise of a 1.5 hour session which focuses on an educational component, discussions and active learning practice activities to apply lesson material. Additionally, participants will be given take home exercises to practice outside a classroom setting. The sessions will be conducted in small groups of 4-6 people.

Intervention Type: BEHAVIORAL

General Education

The active control intervention will be a general education class consisting of real world knowledge and factual information on various topics unrelated to memory. This intervention will follow the same format as the memory self-efficacy training arm. One 1.5 hours session every week for 6 weeks, in small groups.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Subjective memory complaints within past 5 years

2. Objective memory impairment below age norms on standardized cognitive testing

3. Score below 25 on Montreal Cognitive Assessment

4. Scores 1.5 standard deviations below age norms on memory testing

5. Unimpaired performance in Activities of Daily Living

6. Intact general cognition

7. Fluently read, write and speak English

8. Right handed

Exclusion Criteria

1. Co-morbidity that would impact cognition (depression, anxiety, stroke)

2. Prior diagnosis of dementia of any type

3. Use of prescription or recreational drug use that would impact cognition (excluding hormone replacement therapy)

4. Uncorrected visual or auditory deficits/impairments

5. Current participation in alternate study

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western BrainsCAN

UNKNOWN

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Nagamatsu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Community

London, Ontario, Canada

Countries

Canada

Other Identifiers

BSCAN1920

Identifier Type: -

Identifier Source: org_study_id